01 1Morepen Laboratories
01 1DAPAGLIFLOZIN AMORPHOUS
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-03-03
Pay. Date : 2025-01-06
DMF Number : 36898
Submission : 2022-03-14
Status : Active
Type : II
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Morepen Laboratories Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is DAPAGLIFLOZIN AMORPHOUS, with a corresponding US DMF Number 36898.
Remarkably, this DMF maintains an Active status since its submission on March 14, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 03, 2025, and payment made on January 06, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
